The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Sr Glove, Nu Glove, Highstress Model 801, Model 802, Model 803.
| Device ID | K093696 |
| 510k Number | K093696 |
| Device Name: | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 |
| Classification | Polymer Patient Examination Glove |
| Applicant | CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD #240, DIAMOND BAR Diamond Bar, CA 91765 |
| Contact | Nick Wang |
| Correspondent | Nick Wang CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD #240, DIAMOND BAR Diamond Bar, CA 91765 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-30 |
| Decision Date | 2010-02-12 |